Wearable device

ABSTRACT

A wearable device includes a unitary first frame assembly which is integrally formed from first and second polymeric materials. The first frame assembly has a first frame portion formed by the first polymeric material and extends around part of a second frame portion formed by the second polymeric material. The first frame member includes a flexible first shell and a first connecting portion which depends from the first shell. The second frame portion forms part of the first shell and continuously extends to the first connecting portion without interruption. The second polymeric material has greater rigidity than the first polymeric material. The device also includes a second frame assembly having a second connecting portion which links to the first connecting portion.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/232,199, filed on Sep. 12, 2008, now U.S. Pat. No. 8,043,244, whichclaims the benefit of U.S. Provisional Application No. 60/960,048, filedSep. 13, 2007.

FIELD OF THE INVENTION

The present invention relates generally to the field of wearabledevices, such as those pertaining to orthopedic and prostheticapplications, and more particularly to a wearable device that providesstability, protection, support, rehabilitation, and/or unloading to aportion of the human anatomy in a streamlined and light manner.

BACKGROUND

A variety of wearable devices are available for orthopedic andprosthetic applications for providing stability, protection, support,rehabilitation and/or unloading a portion of the human anatomy. Knowndevices, however, are often associated as being bulky and heavy, andfurther costly requiring numerous manufacturing processes to produce.

An example of a wearable device is a knee brace. As is well understood,knee braces are widely used to treat a variety of knee infirmities. Suchbraces may be configured to impart forces or leverage on the limbssurrounding the knee joint in order to relieve compressive forces withina portion of the knee joint, or to reduce the load on that portion ofthe knee. Moreover, in the event that knee ligaments are weak andinfirm, a knee brace may stabilize, protect, support, unload, and/orrehabilitate the knee.

The knee is acknowledged as one of the weakest joints in the body, andserves as the articulating joint between the thigh and calf musclegroups. The knee is held together primarily by small but powerfulligaments. Knee instability arising out of cartilage damage, ligamentstrain and other causes is relatively commonplace since the knee jointis subjected to significant loads during the course of almost any kindof physical activity requiring the use of the legs.

A healthy knee has an even distribution of pressure in both the medialand lateral compartments of the knee. It is normal for a person with ahealthy knee to place a varus moment on the knee when standing so thatthe pressure between the medial and lateral compartments is uneven butstill natural.

One type of knee infirmity that many individuals are prone to having iscompartmental osteoarthritis. Compartmental osteoarthritis may arisewhen there is a persistent uneven distribution of pressure in one of themedial and lateral compartments of the knee. Compartmentalosteoarthritis can be caused by injury, obesity, misalignment of theknee, or simply due to aging of the knee.

A major problem resulting from osteoarthritis of the knee is that thesmooth cartilage lining the inside of the knee wears away. This leads toa narrowing of the joint space with the development of cysts anderosions in the bone ends. Because of the narrowing of the joint, bonecomes directly in contact with bone, and an uneven distribution ofpressure develops across the knee which may result in the formation ofbone spurs around the joint. All of these changes ultimately lead toincreasing pain and stiffness of the joint.

While there are no cures to osteoarthritis, there are many treatments.Individuals who have a diagnosis of isolated lateral or medialcompartmental osteoarthritis of the knee are confronted with a varietyof treatment options such as medications, surgery, and nonsurgicalinterventions. Nonsurgical interventions include the use of canes,lateral shoe wedges, and knee bracing.

Knee bracing is useful to provide compartment pain relief by reducingthe load on the compartment through the application of an opposingexternal valgus or varus moment about the knee joint. Unloading kneebraces have been shown to significantly reduce osteoarthritis knee painwhile improving knee function.

While known knee braces are successful at reducing pain or atstabilizing a knee joint, many users find these braces to be bulky,difficult to don, complicated to configure, and uncomfortable to wear.For these reasons, the exemplary embodiments described herein havestreamlined features capable of providing relief for medial or lateralcompartmental osteoarthritis, or functional stability of the kneewithout the attendant drawbacks of known unloading knee braces.

The concepts described in connection with the exemplary knee braceembodiments may be extended to a variety of wearable devices that areconfigured to be secured to and/or support numerous portions of anatomy.

SUMMARY

The wearable device disclosed herein may be provided in the form of anunloading type knee brace, in accordance with the principles describedin U.S. Pat. No. 7,198,610, granted Apr. 3, 2007, and incorporatedherein by reference.

The exemplary wearable device disclosed herein provides a lightweight,low cost alternative to existing knee braces by providing a unitary kneebrace that has a frame defined by a continuously formed proximal shell,hinge, and distal shell. Thus the entire frame and hinge assembly may becontinuously formed in a one piece construction, for example, by the useof injection molding techniques. Overmolding techniques and materials,such as those described in U.S. patent application publication2008/0195014, and incorporated herein by reference, may be utilized toform the unitary frame and hinge, such that the proximal and distalshell members are substantially flexible, while the hinge has a greaterstiffness than the proximal and distal shell members.

Further, with the addition of at least one strap that may also be formedby injection molding techniques and which is vastly adjustable, a highlyversatile, lightweight, and low cost unitary knee brace is provided thatmay be sold off-the-shelf or over-the-counter to many different personshaving a variety of different leg geometries.

The knee brace may incorporate injection molding and overmoldingtechniques to create a unitary frame and hinge. The frame thus formedmay define at least two discrete regions of materials with the firstregion having a greater stiffness than the second region, or vice versa.Preferably, the frame is continuously formed such that the thicknessesof the shells blend into portions of the hinge so as to secure thesecomponents together.

In a particular embodiment, the knee brace has a unitary frame definedby a proximal shell, a hinge continuously extending from the proximalshell, and a distal shell continuously extending from the hinge. Theproximal and distal shells and hinge may define the first region ofgreater stiffness centrally located along the proximal and distalshells, and the hinge, and the second region generally surrounding andbordering the first region at the proximal and distal shells.

The proximal shell may define a proximal frame segment that extends fromthe proximal frame generally towards the distal frame. The proximalframe segment includes holes that provide ventilation, reduced weight,and flexibility. The proximal frame segment also includes a projectionfor connecting to a first strap connector.

A first strap assembly, which may also be formed by injection moldingand/or overmolding techniques, is provided to connect to both theproximal and distal shells. The first strap assembly includes a firststrap and a strap connector such that the first strap is selectively andadjustably positionable relative to the proximal shell via a first strapconnector and is fixedly secured to the distal shell.

The first strap assembly may also include a buckle assembly having alocking device securable with an opening defined on the distal shell maybe provided to removably secure the first strap to the distal shell. Aflexible extension member may be provided to removably secure the firststrap to the distal shell. In this manner, the first strap assembly maybe adjusted to provide tightening and unloading forces to users havingvaried geometries of legs and knee joints, irrespective of theparticular leg and knee geometry.

A second strap assembly having a similar configuration to the firststrap assembly may also be provided for connection to the proximal anddistal shells. The first and second strap assemblies may intersect orcross at a position generally opposed to the hinge. The first and secondstrap assemblies may include substantially inelastic portions, such asthe strap connectors, so that they do not stretch when the knee brace issecured to the leg.

The hinge may have an undulating profile formed along the anterior andposterior faces thereof to aid with extension and flexion of the kneebrace when the brace is secured to the leg. The hinge defines a geometryproviding greater strength and stiffness than at least one of theproximal and distal shells such that the hinge permits translation ofthe proximal shell relative to the distal shell in flexion and extensiondirections.

The hinge may likewise be formed so as to limit a range of motion in theflexion and extension directions such that the hinge geometry isconfigured to resist rotation. For example, the hinge may be slightlybiased in the flexion direction in that the hinge geometry has apredetermined bend favoring flexion, and limiting extension. However,the hinge geometry is preferably configured such that the hinge can onlybend so far to a certain degree in the flexion direction.

The hinge may also define an undulating profile delimited by breaksformed along lateral and medial facing sides thereof to aid withvarus/valgus rotation of the knee brace when the brace is secured to theleg. Or in the alternative, the hinge may be reinforced with elongateribs running the length of the hinge to resist lateral and medialmovement of the leg.

Additional features of the knee brace may include padding or ventilatedpadding material provided as an interface between the proximal anddistal shells and a user's body, or between the straps and the user'sbody. Further, openings, holes, or slots may be provided in any or allof the shells and straps to aid with ventilation, reduce weight, and/orprovide flexibility.

According to another embodiment of a wearable device, a unitary firstframe assembly is integrally formed from at least first and secondpolymeric materials. A first frame portion is formed by the firstpolymeric material and extends around at least part of a second frameportion formed by the second polymeric material. The first frame memberincludes a flexible first shell and a first connecting portion dependingfrom the first shell, and the second frame portion forms part of thefirst shell and continuously extends to the first connecting portionwithout interruption. The second polymeric material may have a greaterrigidity than the first polymeric material. The wearable device may alsoinclude a second frame assembly having a second shell and a secondconnecting portion linking to the first connecting portion.

In accordance with any of the embodiments described herein of a wearabledevice, a strap may be provided which is formed from at least twodifferent polymeric materials each having different rigidity properties.The strap secures to the first shell and is selectively positionable atpredetermined locations on the second shell. A first polymeric materialmay form a longitudinal core of the strap, and a second polymericmaterial may form a peripheral edge portion surrounding at least part ofthe longitudinal core. The first polymeric material has greater rigiditythan the second polymeric material. This particular strap can be formedsuch that the longitudinal core is substantially inelastic whereas theperipheral edge portion is substantially soft thereby providing apressure-relieving feature for the wearer of the device.

The numerous advantages, features and functions of embodiments of awearable device will become readily apparent and better understood inview of the following description and accompanying drawings. Thefollowing description is not intended to limit the scope of wearabledevice, but instead merely provides exemplary embodiments for ease ofunderstanding.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a front lateral side perspective view of an embodiment of awearable device in the form of a knee brace according to the presentdisclosure;

FIG. 2 is a front medial side perspective view of the knee brace of FIG.1 with the straps of the brace unbuckled;

FIG. 3 is a front medial side exploded view of the components of theknee brace of FIG. 1;

FIG. 4 is a rear medial side exploded view of the frame and straps ofthe knee brace of FIG. 1;

FIG. 5 is a magnified exploded view of the hinge and straps, connectors,and buckles of the knee brace of FIG. 1;

FIG. 6 is a plan view of an embodiment of a strap according to thewearable device;

FIG. 7 is an elevational view of an embodiment of a hinge deviceaccording to the wearable device; and

FIG. 8 is an elevational view of another embodiment of a hinge deviceaccording to the wearable device.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof, and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate an exemplary embodiment of a wearabledevice, and in no way limit the structures or configurations of awearable device according to the present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Environment and Context

An embodiment of a wearable device in the form of a knee brace isprovided to reduce the effect of osteoarthritis in a knee joint, orstabilize a knee joint that has been weakened by injury or otherinfirmities. Although the illustrated embodiment shows a hingepositioned on the medial side of the knee brace and the strapspositioned on the lateral side of the knee brace, it will be understoodthat the knee brace may be configured to reduce or cure both medial andlateral knee joint infirmities, and thus, the hinge may be positioned onthe lateral side of the knee brace and the straps may be positioned onthe medial side of the knee brace.

The knee brace embodiment of the disclosure is particularly adapted fora human knee joint, and may be dimensioned to accommodate differenttypes, shapes and sizes of human joints, appendages, and otheranatomical portions. In addition, embodiments may be provided to orientprincipal forces exerted by strap systems of the embodiments at anydesirable location to treat knee infirmities.

For explanatory purposes, the knee brace embodiment described herein isdivided into sections which are denoted by general anatomical terms forthe human body. Each of these terms is particularly used in reference toa human leg which is divided in similar sections with a proximal-distalplane generally extending along the meniscus of the knee between thefemur and tibia (i.e., femoral and tibial leg portions, respectively).

The embodiment of the knee brace is also divided into anterior andposterior sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg. Each of the anterior and posterior sections isfurther divided about the center of the knee by a transverse orproximal-distal plane and median, sagittal or lateral-medial planes.

The anatomical terms described herein are not intended to detract fromthe normal understanding of such terms as readily understood by one ofordinary skill in the art of orthotics. It will also be understood that,while the invention is discussed in connection with a knee brace, theprinciples described herein can be extended to a variety of orthopedicand prosthetic devices, and any other device that would be wearable andemploy the features described herein.

B. Detailed Description of Wearable Device Embodiments

As discussed above, an exemplary embodiment of the wearable device isdescribed by way of example by the embodiment of a knee brace. The kneebrace disclosed herein may be of an unloading, osteoarthritic knee braceof a type generally described in U.S. Pat. No. 7,198,610, incorporatedherein by reference. Accordingly, the description in connection withthis particular embodiment focuses on the structure, materials, andconfiguration of a particular embodiment of an unloading, osteoarthriticknee brace, without belaboring the particular effects and modalities fortreating osteoarthritis in the knee joint.

Referring to FIGS. 1-5, the knee brace 10 is suitable for stabilizing,protecting, supporting, unloading, and/or rehabilitating the knee. Asshown, the knee brace 10 is composed of a unitary and continuouslyformed frame 12 that is configured to engage the limbs around, andsupport, the knee joint.

The unitary frame 12 includes a proximal (first) frame portion, assemblyor shell 14, a hinge 18, and a distal (second) frame portion, assemblyor shell 16. The proximal shell 14 has an extending portion along themedial side thereof that continuously forms the hinge 18. The hinge 18extends along the medial side and is continuously formed with the distalshell 16. The proximal and distal shells have a flexible arcuategeometry capable of forming a variety of curvilinear profiles toaccommodate a wearer's leg.

This continuous, unitary configuration of the proximal and distal shells14, 16, and the hinge 18 may be formed in any suitable manner, such asby casting, machining, or injection molding. Materials for use asproximal and distal shells 14, 16, and the hinge 18 may includepolymeric materials, carbon or glass fiber and epoxy composites, metals,such as aluminum, or any other suitable material. It will be recognizedthat different materials may be used for each of the components, whilestill maintaining the continuous, unitary construction of the knee brace10.

As shown in FIGS. 1-4, the proximal and distal shells 14, 16 eachinclude a main portion that extends along the medial side of the kneebrace 10 and a substantially horizontally extending arcuate portionconfigured to extend around the anterior portion of the leg, and aroundthe lateral side of the leg. The proximal and distal shells 14, 16 aresuitably formed of a material that provides support to the knee jointand leg, while being flexible enough to allow the proximal and distalshells 14, 16 and the horizontally extending arcuate portions to conformto the geometry of the leg and knee joint of the user. It is understoodthat composite materials, polymeric materials, such as polyethylene, ormetals, such as aluminum, are materials suitable to achieving supportfor the knee joint and leg while providing suitable flexibility.

The various components of the frame, including the proximal and distalshells, and the hinge, may be formed from different materials andconnected together, or may be formed with areas having greaterthicknesses than in other areas in order to strengthen certain areas ofthe frame relative to other areas.

In certain variations, these components of the frame may be formedwithout interruptions. For example, the proximal shell can becontinuously formed with the hinge such that there is no structure(e.g., fasteners or glues) that connects the proximal shell to the hingeother than the materials forming these features, be it throughmechanical or chemical interlocking. According to one variation,polymeric material forming part of the proximal shell continuouslyextends to form part of the hinge. This may be done while injectionmolding the proximal shell and at least a portion of the hinge together.

In another variation, a first polymeric material forming part of theproximal shell interlocks with apertures or other interlocking structureof the hinge. This may be done by first injection molding at least apart of the hinge and then injection molding the proximal shell over orpartly over the already formed hinge. At least a portion of the hinge,however, can be formed from the first polymeric material or anotherpolymeric material.

Projections 52 are provided along the surfaces of both of the proximaland distal shells 14, 16. Such projections may be utilized to providelocalized regions of increased rigidity or toughness. The projections 52also provide traction points on the surfaces of the proximal and distalshells 14, 16.

In order to provide ventilation for the user when the knee brace 10 issecured to the leg, so that perspiration may evaporate therethrough,slots or openings 48 are defined between the projections 52 within theproximal and distal shells 14, 16. While both the projections 52 and theslots 48 are shown canted at an angle relative to the horizontal, othersuitable configurations will be readily recognized, such as verticallyextending slots and projections. The slots or openings 48 also reducethe weight of the knee brace 10 by removing material therefrom andfurther impart flexibility to portions of the proximal and distal shells14, 16.

In a preferred embodiment shown in FIG. 1, the proximal and distalshells 14, 16 are overall substantially flexible to allow the shells toconform to the outline and contours of the leg 50. Specifically, whilethe proximal and distal shells 14, 16 should have a degree of toughnessor rigidity to provide support to the leg and knee joint, as discussedabove, they also are flexible enough to allow the proximal and distalshells 14, 16 to conform to the geometry of the leg and knee joint whensuitable forces are applied, for example via strapping assemblies.

Referring to FIGS. 1-3, an additional feature of the embodiment of theknee brace 10 that provides comfort and structures for affixing straps,as will be discussed in detail below, is the secondary, discrete regionsof material integrally formed with the proximal and distal shells 14,16.

As previously discussed, the proximal and distal shells 14, 16 include adiscrete rigid, hard, and/or tough region 46 that essentially defines acentral portion along the proximal and distal shells 14, 16 and that isrigid and tough enough to provide support to the knee brace 10 and theleg, yet still allows the proximal and distal shells 14, 16 to besubstantially flexible so as to conform to the geometry of the leg andknee joint. This region 46 has a first stiffness consistent with thesefeatures. In view of the unitary form of the frame, a thickness of theproximal shell may blend into a thickness of the hinge, as well as athickness of the distal shell may blend into a thickness of the hinge.

In addition, a discrete flexible and/or elastic region 44 generallysurrounds, and is integrally formed with, region 46. Discrete region 44is formed so as to have less stiffness than region 46. In this manner,region 44 essentially provides a compliant, pressure relieving interfacebetween the harder region 46 and the leg and knee joint of the user. Theregion 44 further may provide additional frictional engagement betweenthe proximal and distal shells 14, 16 and the leg of the user, due tothe lower stiffness of the region 44.

The discrete region 44 is distinguished from the region 46 in that itpreferably has a softer texture, and that region 46 is also strongerthan region 44. More specifically, the discrete region 44 has a hardnessthat is lower than the hardness of the discrete region 46. The twodiscrete regions 44, 46 may be integrally formed using any knowntechnique, such as casting, or injection molding.

According to an exemplary embodiment, the region 46 and the region 44are formed from materials having different hardnesses. In thisvariation, the region 46 and the region 44 are injection moldedthermoplastics that are integrally molded together. An exemplarycombination of materials comprises thermoplastic polyurethane elastomerssold under the name ELASTOLLAN by BASF group.

In making the shells 14, 16 of this variation, the main frame 12 isfirst fabricated by being formed by a first mold. A first material, suchas ELASTOLLAN S60D53N, is injected into the mold so as to result in theformation of the main region 46 of the shells 14, 16. The molded mainframe 12 is then transferred to another, larger second mold which formsthe shape of the shells 12, 14. The main frame 12 is secured andcentered in the second mold. A second material, such as ELASTOLLANC60A10W, is injected into the second mold so as to contact the mainframe 12 and form the discrete region 44 therearound. Due to thesimilarity in composition of the first and second materials, the secondmaterial of the region 44 bonds to the first material of the region 46as it is formed in the second mold. In this variation, the firstmaterial has a hardness that is greater than the second material.

A significant advantage to this configuration is that the combination ofa flexible, yet tough region 46 with a softer region 44 surrounding andbordering the tough region 46 of the shells 14, 16 provides asubstantially comfortable feature to the knee brace.

Another advantage to this variation is that the shells 14, 16 and theregion 44, may be pigmented in different colors. This results in anappearance that results in a piping around the periphery of the shells14, 16 which provides a visually pleasing appearance. For example, thefirst material used for forming the region 46 of the shells 14, 16 mayhave a black pigment, whereas the second material used for forming theregion 44 may have a gray pigment.

While similar materials are described in connection with this variation,it will be noted that dissimilar materials may also be used. Forexample, polyethylene, polyurethane and other thermoplastics may be usedfor forming the main region 46 of the shells 14, 16, and suitablematerials such as vinyl, rubber or thermoplastic elastomers may be usedfor forming the region 44. Other methods for forming the main region 46of the shells 14, 16 with the region 44 may be found in U.S. Pat. Nos.5,445,602 and 5,716,335, incorporated herein by reference. Moreover, asoft flexible region may be mechanically adhered, such as by anadhesive, to a shell having ledge, slotted or groove portions upon whichthe flexible region may be adhered and that does not interlock with anystructure of the shell.

Additional comfort may be provided by the utilization of padding 28, 30between the shells 14, 16 and the leg of the user. Such padding may beventilated, with for example holes or channels, so that perspiration mayevaporate from the skin of the user. Exemplary configurations ofventilated padding are disclosed in U.S. patent application Ser. No.11/312,330, filed on Dec. 21, 2005, published as U.S. publication no.2006/0135900 A1 on Jun. 22, 2006, and herein incorporated by reference.

In order to provide additional support to the brace 10 while stillallowing the necessary amount of flexion/extension and varus/valgusmovement of the knee joint, hinge 18 is continuously formed between theproximal and distal shells 14, 16. Hinge 18 is integrally formed withthe shells 14, 16 in any suitable manner, such as by injection molding.Hinge 18 is formed to have a greater stiffness than the shells 14, 16,so as to provide the appropriate amount of resistance and support to theknee joint. This may be accomplished by utilizing a different materialfor the hinge 18 than the shells 14, 16, and/or by altering the geometryof the hinge.

As shown in FIGS. 1-3, the hinge 18 has a contoured covering 78 thataccommodates the geometry of the knee joint. Alternatively, the covering78 may represent at least one plate covering components formed by theframe which form a hinge. Thus, the hinge may extend out of theanterior/posterior plane and/or the medial-lateral plane, or parallelplanes thereto. Alternatively, the hinge may be arranged to limitmovement along the medial-lateral plane, and favor only certain degreesof extension and flexion of the knee.

Referring to FIG. 5, the hinge 18 has an undulating profile 88 formedalong anterior and posterior faces thereof and an undulating profileformed by side breaks 90 along the lateral and medial facing sidesthereof. The undulating profiles aid with flexion of the hinge toprovide the desired flexion/extension and varus/valgus movement of theknee joint. For example, the hinge may be slightly biased in the flexiondirection in that the hinge geometry has a predetermined bend favoringflexion, and limiting extension. However, the hinge geometry isconfigured such that the hinge can only bend so far to a certain degreein the flexion direction.

The hinge may also define an undulating profile delimited by breaksformed along lateral and medial facing sides thereof to aid withvarus/valgus rotation of the knee brace when the brace is secured to theleg. Or in the alternative, the hinge may be reinforced with elongateribs running the length of the hinge to resist lateral and medialmovement of the leg.

The hinge may be formed and configured to accommodate or facilitatebending of the hinge in certain directions, or limiting the range ofmotion in certain directions. For example, the hinge may be slightlybiased in the flexion direction in that the hinge geometry has apredetermined bend favoring flexion, and limiting extension. However,the hinge geometry is configured such that the hinge can only bend sofar to a certain degree in the flexion direction.

Turning now to the arrangements provided to secure the knee brace 10 toa user's leg and knee joint, first and second strap assemblies includingfirst and second straps 20, 22 connect to the proximal and distal shells14, 16 in a manner providing much versatility for accommodating manydifferent geometries of leg and knee joints. The straps 20, 22 may beformed from any suitable material, such as plastic, so as to be flexibleenough to wrap around and configure to the geometry of the leg and kneejoint. The straps 20, 22 may be formed in any known suitable manner,such as casting or injection molding. Each of the straps 20, 22 mayinclude a cushion feature 42, such as foam or a textile pad that issecured thereon for enhanced rotational prevention and additionalcomfort. Of course, cushion feature 42 may be any suitable pad, such asa ventilated pad of the type previously discussed.

With particular reference to FIGS. 1 and 3, the flexible and/or elasticregion 44 forms proximal and distal frame segments 21, 23 that protrudefrom the proximal and distal shells 14, 16 and generally extend towardsthe distal and proximal shells 16, 14, respectively. Additionally, theflexible and/or elastic region 44 forms a proximal frame strap 25extending horizontally from the horizontal arcuate proximal frameportion and a distal frame strap 27 extending horizontally from thehorizontal arcuate distal frame portion. Each of the proximal and distalframe straps 25, 27 may include a cushion feature 40, such as foam or atextile pad that is secured thereon for enhanced rotational preventionand additional comfort. Of course, cushion feature 40 may be anysuitable pad, such as a ventilated pad of the type previously discussed.

The proximal and distal frame segments 21, 23 and frame straps 25, 27serve as anchor points for the first and second straps 20, 22 in amanner to be described below.

The proximal and distal frame segments 21, 23 define openings 84, 86therethrough along substantially the entire frame segment. The openings84, 86 are shown as parallel pairs of slots, however, any suitableconfiguration, such as parallel single elongated slots, or such ascircular or elliptical holes may be utilized. The openings 84, 86 mayprovide for ventilation, reducing the weight, and/or increasing theflexibility of the frame segments.

The proximal and distal frame segments 21, 23 further include lockingprojections 36, 38 that extend from the anterior surfaces respectivelythereof. The locking projections 36, 38 are illustrated as substantiallyrectangular projections oriented perpendicularly to a longitudinaldirection of the respective frame segments. Of course, any suitableshape or form or arrangement of locking projection may be provided, suchas a pair of cylindrical locking projections, or elliptical lockingprojections.

The proximal and distal frame straps 25, 27 also define openings orslots 67 therethrough. Again, the openings 67 are shown as parallelpairs of slots, however, any suitable configuration, such as parallelsingle elongated slots, or such as circular or elliptical holes may beutilized.

Like the proximal and distal frame segments 21, 23, and the proximal anddistal frame straps 25, 27, the straps 20, 22 define a series ofopenings 92 provided in a plurality of rows defined along substantiallythe entire length of the straps. As previously stated the openings 92are shown as parallel rows or pairs of slots, however, any suitableconfiguration, such as parallel single elongated slots, or such ascircular or elliptical holes may be utilized.

In order to provide a selective positionable connection between thefirst and second straps 20, 22 and the proximal and distal shells 14,16, respectively, the first and second strap assemblies may also includefirst and second strap connectors 24, 26 may be utilized. The first andsecond strap connectors 24, 26 define a slot or opening 80, 82 locatedat or near a first end thereof, and further define projections 54extending from the posterior surface and located at or near a second endopposed to the first end.

As shown in FIG. 4, the projections 54 include two sets of pairs ofrectangular projections that are shaped and configured to releasablyfrictionally engage and interlock with any pair of the slots or openings94 defined in the straps 20, 22. In this manner, the first and secondstrap connectors 24, 26 may be selectively positioned along the lengthof the straps 20, 22 in order to effectively adjust the length thereof.Since, as previously mentioned, the openings 94 may have any suitable ordesired shape, it will be recognized that the projections 54 may haveany corresponding suitable or desired shape as the openings 94 in orderto frictionally interlock therewith.

At the opposed ends of the strap connectors 24, 26, the slot or openings80, 82 are shaped and configured to releasably frictionally fit over theprojections 36, 38 of the first and second frame segments 21, 23. Again,it will be recognized that any suitably corresponding shape may be usedfor the openings 80, 82 and the projections 36, 38. Accordingly, thestrap connectors 24, 26 selectively positionably connect the first andsecond straps 20, 22 to the proximal and distal shells 14, 16.

The strap connectors 24, 26 are formed to be substantially inelasticsuch that when the first and second straps 20, 22 are connected to theproximal and distal shells 14, 16, little or no stretching, which maylead to a less secure fit of the brace on the leg, occurs.

The strap assemblies may also include proximal and distal buckleassemblies 32, 34 secured to the ends of the first and second straps 20,22 that are opposed to the ends where the strap connectors 24, 26 areconnected. The buckle assemblies 32, 34 define a low profile buckleassembly which locks the straps 20, 22 in position relative to theshells 14, 16 and functions in a manner similar to that described inU.S. Pat. No. 7,198,610. The buckle assemblies 32, 34 each include afirst buckle flange 69 integrally formed with, or secured to, the end ofthe straps opposed to the ends connected via the strap connectors 24,26.

Each of the first buckle flanges 69 include a projection 70, 76positioned at or near a first end of the buckle flange 69 along ananterior surface thereof. The projections 70, 76 are rectangularlyshaped, but may take any suitable shape or form. The projections 70, 76and the buckle flanges 69 are configured to releasably frictionallyengage a mounting slot 94, 58 and retaining element 56, 60 formed on therespective proximal and distal shells 14, 16. The retaining elements 56,60 are formed as recesses along the proximal and distal medial sideportions of the respective proximal and distal shells 14, 16. Therecesses are generally shaped so as to receive the buckle assemblies 32,34 therein to provide a low profile brace and to reduce the risk of thebuckles catching on clothing or other foreign objects.

The mounting slots 94, 58 are shaped to releasably frictionally engagethe projections 70, 76 of the buckle flanges 69. As previouslymentioned, the shape of the mounting slots 94, 58 may be any suitablecorresponding shape to the shape of the projections 70, 76.

Returning to the buckle assemblies 32, 34, which are similarlyconstructed and illustrated in FIGS. 2-5, a second buckle flange 72 ispivotably connected to a second end opposed to the first end of thefirst buckle flange 69. The second buckle flange 72 also defines arecess between first and second ends that is shaped and configured toreceive a third buckle section 74 therein. The third buckle section 74is pivotably connected at a first end to the second buckle flange 72 atan end of the second buckle flange 72 opposed to the pivotal connectionbetween the second buckle flange 72 and the first buckle flange.

The third buckle flanges 72 are secured or connected at a second end torespective first ends of proximal and distal flexible extension members62, 64. The flexible extension members 62, 64 work in concert with thebuckle assemblies 32, 34 to selectively lock and secure the brace 10 tothe user's leg and knee joint, as will be described in more detailbelow.

The flexible extension members 62, 64 respectively include pairs ofprojection members 66, 68 at or near second ends thereof opposed to thefirst ends. The projection members 66, 68 are formed along posteriorsurfaces thereof and are configured in the same manner as projections 54described above. Similarly to projections 54, the projection members 66,68 are configured to frictionally, releasably engage and interlock withselective pairs of the openings 67 defined in the proximal and distalframe straps 25, 27. It will again be recognized that any suitablecorresponding shapes or configurations for the openings 67 andprojection member 66, 68 may be utilized. In this manner, the effectivelength of the respective buckle assemblies and flexible extension membermay be increased or decreased as needed.

It will be noted that the components of the buckle assemblies 32, 34 andthe flexible extension members 62, 64, as well as the straps 20, 22 mayall be integrally injection molded together as a unitary piece or unit.Alternatively, the components may be injection molded separately andconnected utilizing traditional pivot pins for the pivoting connections.

In use, a user can place the knee brace 10 on the leg with the proximalshell 14 engaging the thigh and the distal shell 16 engaging the shinand calf. The straps 20, 22 may be connected to the proximal and distalshells 14, 16 via the first and second strap connectors 24, 26, and thefirst and second flexible extension members 62, 64. The connections ofthe straps 20, 22 to the proximal and distal shells 14, 16 at the firstand second frame segments 21, 23 and the proximal and distal framestraps 25, 27 may be adjusted in order to provide the necessary amountof forces to provide unloading of the lateral component of the kneejoint.

Once the straps 20, 22 have been connected to the proximal and distalshells 14, 16, the proximal and distal buckle assemblies 32, 34, and inparticular, the first buckle flanges 69 and projections 70, 76, may beengaged with the mounting slots 94, 58 and retaining elements 56, 60formed on the respective proximal and distal shells 14, 16. The flexibleextension members 62, 64 bend to allow the straps 20, 22 and the buckleassemblies 32, 34 to encircle the posterior portions of the leg.

Once this is accomplished, the straps 20, 22 basically form acircumferential shape, along with the proximal and distal shells 14, 16,to surround the anterior and posterior portions of the thigh/hamstringand shin/calf. In order to secure the knee brace 10 in position, thebuckle assemblies 32, 34 are moved from a disengaged position to anengaged position.

As shown in FIG. 2, the buckle assemblies 32, 34 are in a disengagedposition. The second buckle flange 72 acts as a lever arm that may bemanipulated in and out of essentially flush engagement with the firstbuckle flange 69 to either engage or disengage the buckle assemblies 32,34 in a manner that will be recognized by a skilled artisan.

As illustrated, the buckle assemblies 32, 34 include a curved profilesuch that they conform to the leg of a wearer of the brace. This impartsa more streamlined buckle assembly and further prevents the buckleassembly from snagging on clothing or acting as an impediment to thewearer of the brace.

It will be recognized that resilient releasable locking structures maybe provide to the buckle assemblies 32, 34 in order to prevent theaccidental disengagement of the buckle assemblies. Such releasablelocking structures are described in detail in U.S. Pat. No. 7,198,610.

In a variation of the straps, as illustrated in FIG. 6, an elongatestrap 100 is formed with at least two discrete regions which arecontinuously formed without interruption. The first region 102 is formedwith a first polymeric material, and generally defines the longitudinalcore of the strap 100. A second region 104 forms a peripheral edgeportion to the first region, and is formed from a polymeric materialwhich is less rigid than a polymeric material used to form the firstregion 102. While the second region is preferably injection molded overthe periphery of the first region and interlocked with or bonded to thefirst region, other suitable means may be employed to secure the secondregion to the first region of the strap.

The first region may be configured so that it is substantiallyinelastic, or alternatively elastic, depending on the usage of thewearable device. The peripheral edge portion is preferably formed as asoft, pressure relieving feature for the wearer of the device.

The strap 100 may form a plurality of openings 106 which have anintegrally formed grommet or reinforcement ring 108 which is formed froma material (e.g., polymeric material) that may be either tougher oralternatively less rigid than the first polymeric material of the strap100. The properties of the ring 108 can be adapted to the particularusage, such that a ring tougher than the first region may be formed ifthe first region itself may tear upon repeated usage of engaging theopenings with a corresponding hook or other attachment element, or inthe alternative a soft or flexible ring can be used to assure betterlocking with a hook or other attachment element by maintaining theattachment element in the opening.

A plurality of protrusions 110 may be integrally formed on the firstregion 102 that are arranged to engage the openings 106 or openingsformed on the frame of the brace. These protrusions 110 may be formedfrom the first polymeric material, or alternatively from anotherpolymeric material continuously and integrally formed with the firstregion 102. Other means may be provided to form, attach or adhere theprotrusions to the strap 100, such as fasteners, adhesives or othersuitable means.

In accordance with another embodiment of the device, the device isformed from first and second frame assemblies which together form ahinge. In observing the device 10 depicted in FIGS. 1-5, the hinge 18may be formed by a combination of first and second connecting portionsbelonging to the first and second frame assemblies 14, 16, respectively,and a covering 78 installed or in combination with the hinge 18.

Turning to FIG. 7, one embodiment of a hinge is shown by way of hinge200, which could be adapted in the embodiment of FIGS. 1-5. The hinge200 involves a first connecting portion 202 having a first endintegrally provided without interruption from the proximal frame portion(not shown). The first connecting portion 202 includes an elongatecentral portion 206 and a perimeter edge portion 208 extending along atleast part of the periphery of the central portion 206. The hinge 200also includes a second connecting portion 204 integrally providedwithout interruption from the distal frame portion (not shown), andlikewise includes an elongate central portion 210 and a flexibleperimeter edge portion 212 extending along at least part of theperiphery of the central portion 210.

The peripheral edge portions are formed using a less rigid polymericmaterial than the material forming the central portions in both thefirst and second connecting portions, thereby forming a pressurerelieving section to the hinge. It will be noted that the centralportions can be formed from a polymeric material, fiber reinforcedmaterial, or any other suitable material a non-interrupted andcontinuous structure with the peripheral edge portion and thecorresponding proximal and distal frame portions.

Second end portions 214, 216 of the first and second connecting portions202, 204 each define a head having a generally circular gear portion218, 220. The second end portions 214, 216 are pivotably mounted aboutpivot points 230, 232 of a covering 228 such that the gear portions 218,220 mesh with one another.

Each second end portion 214, 216 is provided with first stop structures224, 234. The first stop structures 224, 234 are located on an anterioror front facing side of the hinge 200 and are arranged to limit rotationof the hinge 260 in the anterior or forward direction of the hinge incombination with stop face 226 formed on the covering 228. The secondstop structure 236 is formed on a generally posterior or rear facingside of the hinge, and is arranged to limit rotation in the posterior orbackward direction of the hinge.

Apertures 230, 232 may be formed in the covering 228 along the path ofthe stop structures as the gear portions 218, 220 rotate. Theseapertures are adapted to receive a screw or pin. The screw or pin can beprovided to block or engage one of the first and second stop structuresto further limit rotation of the hinge.

Strengthening ribs 237 may be provided along the first and secondcentral portions 206, 210 so as to reinforce the first and secondconnecting portions 202, 204 from lateral and medial movement of thehinge 200. Alternatively, the ribs 237 may be replace with openingshaving a similar profile so as to reduce weight and enhance flexibilityof the first and second connecting portions.

FIG. 8 illustrates another embodiment of a hinge 240. In thisembodiment, a first connecting portion 241 includes an elongate centralportion 242 with a peripheral edge portion 244, and an end portionhaving a generally circular head portion 245. A second connectingportion 243 includes an elongate central portion 246 with a peripheraledge portion 248, and an end portion having a generally circular headportion 247. The central portions 242, 246, and peripheral edge portions244, 248 of the first and second connecting portions 241, 243 may besimilarly formed as in the embodiment of FIG. 7. The first and secondconnecting portions 241, 243 are pivotally connected at their headportions 245, 247, so that the first and second connecting portions 241,243 are individually connected to one another. A covering plate 252 maybe used to cover the circular head portions 245, 247.

In view of the above description, an exemplary embodiment of a wearabledevice providing motion control is described. Such a device may beformed substantially in a single unitary frame assembly or in multipleunitary frame assemblies by virtue of injection molding and overmoldingtechniques. Additionally, frame assemblies described herein may becombined in combination with other frame assemblies or components whichare not provided in unitary form. Other components of the device,including the straps and buckle assemblies, may also be injectionmolded, either integrally with or separately from the frame assemblies.

As a result of the solutions provided and described herein, and allequivalents thereof, the device may be provided off-the-shelf orover-the-counter to a large body of the populace at a relatively lowcost, and regardless of the varied geometries of the legs and knees ofthe many different users.

C. Conclusion

While a particular embodiment of a wearable device is discussed aboveutilizing all or substantially all injection molded parts, thecomponents of the knee brace described herein may be formed in anysuitable manner recognized by a skilled artisan, such as casting,machining, stereolithography, or any other suitable process.

The disclosed embodiment of an wearable device provides an improved kneebrace that is lightweight and low cost and has a lower profile than atypical brace.

It is understood that the size of the device and the components thereofcan be adjusted so that an even larger number of different users havingdifferent sized joints and body parts may benefit from the presentdesign.

It is also understood that the locations of the various interlockingprojections and openings can be alternated from those shown, such thatthe positions of the openings and locking projections may be swappedfrom the positions as illustrated herein.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features. In addition to the variations described herein,other known equivalents for each feature can be mixed and matched by oneof ordinary skill in this art to construct a knee brace in accordancewith principles of the present invention.

Although this invention has been disclosed in the context of certainexemplary embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

The invention claimed is:
 1. A method for forming a strap having firstand second regions continuously joined to each other withoutinterruption, comprising the steps of: forming the first region byinjecting a first polymeric material into a first mold, the first regiondefining a longitudinal core of the strap; forming the second region byinjecting a second polymeric material in a second mold about peripheraledge portion to the first region; wherein the first polymeric materialis a first thermoplastic elastomer, and the second polymeric material isa second thermoplastic elastomer; wherein the first and second polymericmaterials are integrally molded together and chemically bonded at leastat an interface between the first and second regions due to a similarityin composition of the first and second polymeric materials, the firstthermoplastic elastomer having greater rigidity than the secondthermoplastic elastomer.
 2. The method according to claim 1, includingthe step of bonding the second polymeric material to the first polymericmaterial as the second polymeric material is formed into the secondregion.